Efficacy of Autologous Fibrin Glue Versus Suture for Conjuntival Autografting in Primary Pterygium Surgery: a Randomized Clinical Trials
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Pterygium Recurrence
Study Overview
Brief Summary
Pterygium is wing-shaped, vascular, fleshy growth that originates on the conjuntiva and that can spread to the corneal limbus and beyond The surgical exeresis with autologous conjunctival autograft technique is the treatment of choice. Commercially available fibrin glue has been used preferentially for graft fixation due to its benefits compared to sutures; However, its cost and the risk of inflammatory immune reaction limit the its use. There are few studies about autologous fibrin glue.
OBJECTIVE: To determine the efficacy of autologous fibrin glue preparation in patients undergoing pterygium resection surgery. To compare with autologous conjunctival graft fixation with suture.
This is a randomized clinical trial. Two patient groups will undergo pterygium excision surgery. Group 1 will have autologous conjunctival graft fixation with autologous fibrin glue and group 2 will have suture graft fixation using 10.0 mononylon. Early and late postoperative surgical results as well as complication rates will be analyzed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •nasal primary pterygium
Exclusion Criteria
- •relapsed pterygium
- •patients with a history of previous eye surgery
- •patients with glaucoma using hypotensive eye drops
- •eye surface diseases
- •eye allergy
- •diabetic patients,
Outcomes
Primary Outcomes
Pterygium Recurrence
Time Frame: 6 months
Recurrence in 6 months
Secondary Outcomes
- Graft Edema(Postoperative day 1, 7, 21 and 30)
- Postoperative Pain(Postoperative day 1, 7, 21 and 30)
- Autograft Retraction(Postoperative day 1, 7, 21 and 30)